Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD) (ELASTIC)

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions

Treatments: Drug: Placebo; Drug: Roflumilast

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01630200

ELASTIC2011

Details and patient eligibility

About

Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis.

Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.

The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.

Enrollment: 80 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 40 years of age
• Smoking history of at least 10 pack years
• Chronic obstructive pulmonary disease at Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II - IV diagnosed according to standard criteria.
• History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year

Exclusion criteria

• Insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period
• History of acute exacerbation 4 weeks prior to run-in period
• Diagnosis of alpha-1-antitrypsin deficiency
• Diagnosis of asthma
• Acute respiratory infections (e.g. pneumonia)
• Severe acute infectious diseases (e.g. active hepatitis, HIV)
• Lung cancer
• Bronchiectasis
• Interstitial lung disease
• Any other relevant lung disease
• Acute myocardial infarction
• Systolic left ventricular dysfunction
• Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade IV
• Haemodynamically significant cardiac arrhythmias or heart valve deformations
• Peripheral arterial occlusive disease
• Acute or chronic renal/hepatic failure
• Active malignancy
• Autoimmune disease
• Pregnant or breastfeeding women
• Women no using or not willing to use adequate contraceptive measures for the duration of the trial
• Hypersensitivity to study medication or placebo
• Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour
• Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

Active arm including patients who receive the study drug (500µg Roflumilast once daily)

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

Control arm including patients who receive the placebo tablet (once daily)

Treatment:

Drug: Placebo